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Knee OsteoarthritisPhase 2NCT04208646

Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells for the Treatment of Knee Osteoarthritis

A Phase 2 study testing Mesenchymal progenitor cells and No mesenchymal progenitor cells in people with Knee Osteoarthritis, run by Shanghai AbelZeta Ltd. at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluate the efficacy and safety of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Mesenchymal progenitor cells and No mesenchymal progenitor cells
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
106 participants
Where
7 sitesChina
Study dates
16 May 2020to 31 Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who understand and voluntarily sign the consent form before this study；
  • According to the diagnostic criteria (American Rheumatology Association, clinical + radiology criteria), patients with knee osteoarthritis are definitely diagnosed；
  • Age: 40-75, males and females；
  • The course of knee osteoarthritis was more than 6 months and less than 10 years;
  • The subjects' WOMAC score was 24-72, and the WOMAC pain score was 7-17 (the WOMAC score at least 48 hours after discontinuation of all painkillers);
  • The Kellgren Lawrence grade (X-ray axial position of knee joint) of subjects was grade II / III;
  • Subjects are generally in good condition and can walk autonomously, except for those who use wheelchairs, walking aids or crutches.

Who cannot join

  • The subject may be allergic to the main cell preparation components (B vitamins, amino acids and so on).
  • The subject received systemic and / or local treatment with autologous and / or allogeneic mesenchymal progenitor cells.
  • The subject has a BMI of over 30.
  • Laboratory test (any item meets): neutrophil absolute number < 1.0 × 10^9 / L, platelet count < 50 × 10^9 / L, serum albumin < 30g / L, serum creatinine > upper limit of normal value range, total bilirubin、alanine aminotransferase、aspartate aminotransferase > upper limit of 2 times of normal value range.
  • The subject has diseases or symptoms may affect VAS, WOMAC and so on.
  • The subject has serious and poorly controlled concomitant diseases, such as (but not limited to) nervous system, cardiovascular, liver, kidney, gastrointestinal and endocrine diseases, which may prevent the subjects from participating in the study according to the judgment of the researchers.
Show all 24Show fewer
  • The subject has an history malignant tumour.
  • The subject has connective tissue disease or rheumatoid arthritis、chondropathy、Chondrocalcinosis articularis、 Hemochromatosis、inflammatory arthropathy、avascular necrosis of femoral head、Paget's disease、hemophilic arthropathy、infectional arthritis、Charcot' s disease、villonodular synovitis or synovial chondromatosis.
  • The subject has severe generalized infectious diseases or local knee infection (including skin and intra-articular infection) in the 3 months prior to this trial.
  • According to the researchers,the subject has disease of lower limbs which may be interfered knee evaluation, for example fibromyalgia, osphyalgia, lumbar disc protrusion and so on.
  • The subject had any other coagulation dysfunction caused by acute or chronic diseases, according to the judgment of the researchers, this coagulation dysfunction may endanger the safety of patients and / or affect the judgment of knee joint evaluation indicators.
  • The subject has received arthroscopic surgery or other open surgery related to knee joint operation in the 6 months prior to this trial.
  • The subject has received other intra-articular injections, including but not limited to hyaluronic acid, hormone, PRP, BMP (bone morphogenetic protein) , hypertonic glucose and so on for KOA in the 3 months preceding the trial.
  • The subject has received aminoglucose or chondroitin sulfate within 1 month before the treatment.
  • The subject has used dexamethasone, prednisone, hydrocortisone and other hormones orally / intravenously within 1 month before the treatment.
  • The subject has undergone knee prosthesis or a plan of knee prosthesis within the trial.
  • The subject has contraindication of MRI, included but not only: the subject installed heart pacemaker, defibrillator, heart bracket, heart valve prosthesis, metal clip after aneurysm surgery, drug infusion device implanted in vivo, any electronic device implanted in the body (nerve stimulator, bone growth stimulator) endovascular coil, strainer, ECG monitor, metal suture, shrapnel or sand of body, plate fixation and steel nail after fracture surgery, artificial cochlea, middle ear shift plant, metallic intraocular foreign body etc; the subject is a claustrophobia, critical ill patient and so on.
  • The subject tests positive for: HIV, HBV, HCV and treponema pallidum.
  • The subject has history of alcoholism, drug abuse, or mental illness in the 3 years prior to this trial.
  • The subject has participated in any other clinical trial in the 3 months prior to this trial.
  • The subject (including male subjects) has fertility, sperm donation or egg donation plans during the trial period; the female subject is pregnant, lactating or having a positive pregnancy test.
  • The subject is legally disabled by reference to the law of the people's Republic of China on the protection of disabled persons (April 2008).
  • The subject has any other unsuitable condition (such as factors reducing the follow-up compliance) to be determined by the investigator.
  • 24.The Kellgren Lawrence grade (X-ray axial position of knee joint) of any knee joint of the subjects was grade IV.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • China-Japan Friendship Hospital

    Beijing, 100029

  • The Second Affiliated hospital of Zhejiang University School of Medicine

    Hangzhou, 310009

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, 200040

  • Shanghai General Hospital

    Shanghai, 200080

  • Shanghai Jiaotong University School of Medicine, Renji Hospital

    Shanghai, 200127

  • Shanghai Sixth People's Hospital

    Shanghai, 200233

  • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

    Shanghai

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Controlled Phase II Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells (AlloJoin®) for the Treatment of Knee Osteoarthritis

Evaluate the efficacy and safety of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy

Read the detailed description

A Multicenter, Randomized, Double-blind, Controlled Phase II Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells (AlloJoin®) Therapy for Knee Osteoarthritis.

This is a multicenter, randomized, double-blinded, phase II clinical trial. Subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects and will be randomly distributed 1:1:1 to different group after signing the ICF and screening tests. Each group was treated for two cycles. The patients were followed up to 48 weeks after the first treatment.

Being tested
Mesenchymal progenitor cells, No mesenchymal progenitor cells
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesenchymal progenitor cellsBiological

    Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra- articular use

  • No mesenchymal progenitor cellsBiological

    No mesenchymal progenitor cells for intra- articular use

Study groups in NCT04208646
Study groupRoleWhat they receive
Mesenchymal progenitor cells Dosage 1ExperimentalMesenchymal progenitor cells low-dose group
Receives: Biological: Mesenchymal progenitor cells
Mesenchymal progenitor cells Dosage 2ExperimentalMesenchymal progenitor cells high-dose group
Receives: Biological: Mesenchymal progenitor cells
No mesenchymal progenitor cellsPlacebo comparatorNo mesenchymal progenitor cells
Receives: Biological: No mesenchymal progenitor cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WOMAC Score

    The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points；96 points mean a worse outcome,will be tested at 24 weeks after the first injection

    Measured: 24 weeks

Secondary outcomes (6)

  1. MRI quantitative analysis of articular cartilage

    Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 24、48 weeks after the first injection

    Measured: 24 weeks,48 weeks

  2. WOMAC Score

    The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points；96 points mean a worse outcome, will be tested at 4、8、12、36、48 weeks after the first injection

    Measured: 4、8、12、36、48 weeks

  3. VAS Score

    Visual Analogue Scale/Score；0-10 points；10 points mean a worse outcome,will be tested at 4、8、12、24、36、48 weeks after the first injection

    Measured: 4、8、12、24、36、48 weeks

  4. SF-36

    The Medical Outcomes Study 36-Item Short-Form Health Survey;0-100 points；100 points mean a better outcome, will be tested at 4、8、12、24、36、48 weeks after the first injection

    Measured: 4、8、12、24、36、48 weeks

  5. Adverse Events and Serious Adverse Events

    AE and SAE, will be assessed at 0d、1、3、4、8、12、24、25、27、28、36、48 weeks

    Measured: 0d、1、3、4、8、12、24、25、27、28、36、48 weeks

  6. Changes of laboratory test indexes and vital signs

    Vital signs, physical examination, clinical laboratory tests:infectious disease check, blood coagulation test , blood check, urine check, blood biochemical test, immunological examination, tumor screening ,will be tested at 0d、1、3、4、8、12、24、25、27、28、36、48 weeks

    Measured: 0d、1、3、4、8、12、24、25、27、28、36、48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2019
  2. Study start16 May 2020
  3. Primary completion30 Jun 2021
  4. Study completion31 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04208646
Sponsor's protocol ID
CBM-ALAM.1-01
Status last verified
May 2023
First submitted
17 Dec 2019
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mesenchymal progenitor cells and No mesenchymal progenitor cells in people with Knee Osteoarthritis, run by Shanghai AbelZeta Ltd. at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WOMAC Score (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04208646.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.

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